Evaluation of chronic toxicological profile of herbo-mineral formulations: Shwaskas Chintamani Rasa and its marketed formulation namely Kas Shwas Hari Rasa.

BACKGROUND: Shwaskas Chintamani Rasa (SKC) and Kas Shwas Hari Rasa (KSH) are the Ayurvedic herbo-mineral formulations. These Ayurvedic formulations contain heavy metals which is the reason of concern and might bring up the safety issue. OBJECTIVE: This research article is aimed to study chronic toxicity of SKC and KSH for safety aspect in Wistar rats. MATERIAL AND METHOD: A study group of 220 healthy rats were divided into six groups. These rats were administered with SKC and KSH formulations where both the formulations were administered for 180 consecutive days. SKC was administered at doses of 58 mg/kg (equivalent to therapeutic dose i.e. TD), 145 mg/kg (2.5 TD), 290 mg/kg (5 TD) and KSH was administered at dose of 58 mg/kg (TD). According to OECD guideline 452, the effect of these formulations was examined on hematology, serum biochemistry and histopathology of various organs. RESULTS: Both the formulations did not produce any signs or symptoms of treatment related toxicity in both male and female Wistar rats at therapeutic dose (TD), 2.5 times TD and 5 times TD. CONCLUSION: Based on these findings, the NOAEL (No observed adverse effect level) for test formulations SKC and KSH tablets in male and female wistar rats concluded to be preclinically safe.

Assessment of Chronic Toxicity of an Ayurvedic Herbo-Metallic Formulation Rasaraj Rasa in Wistar Rats.

Objectives: This study aimed to assess the adverse effects of Rasaraj Rasa tablets after repeated oral administration for 180 days in Wistar rats. Methods: Wistar rats were divided into five groups, of which three were treated with 54, 162, and 270 mg/kg body weight of Rasaraj Rasa, respectively, which correspond to one, three, and five times the proposed human therapeutic dose, for 180 days consecutively. The fifth group (satellite) also received 270 mg/kg body weight of Rasaraj Rasa for 180 days. Body weight and food intake were measured weekly. At the end of the study, all rats were sacrificed, and their blood, serum, and organs were collected and examined using hematology, serum biochemistry, gross pathology, and histopathology tests. In contrast, the satellite group was kept for 4 weeks after treatment. Results: No significant treatment-related toxicological findings were observed in the clinical features, body weight, laboratory findings, and pathological findings of the high-dose treated groups, when compared to those of the control group. Conclusion: The no-observed-adverse-effect-level for Rasaraj Rasa in Wistar rats is set at 270 mg/kg body weight.